Clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII in previously treated patients with severe haemophilia A

Completed

Conditions: Severe haemophilia A
Haematological Disorders
Hereditary factor VIII deficiency

Registration Number: ISRCTN87293301

Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 20

Inclusion Criteria

1. Must have severe haemophilia A (FVIII:C less than 1%; historical value as documented in subject records)
2. Aged greater than 18 and less than 65 years, male
3. Body weight 45 kg to 110 kg
4. Previously treated with FVIII concentrate, at least 150 exposure days (EDs)
5. Immunocompetent (CD4+ count greater than 200/µL)
6. Negative for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) or respective viral load less than 200 particles/µL
7. Freely given written informed consent

Exclusion Criteria

1. Other coagulation disorder than haemophilia A
2. Present or past FVIII inhibitor activity (greater than 0.6 BU)
3. Severe liver or kidney disease (alanine aminotransferase [ALAT] and aspartate aminotransferase [ASAT] levels greater than 5 times of upper limit of normal, creatinine greater than 120 µmol/L)
4. Receiving or scheduled to receive immuno-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to greater than 10 mg/day), or similar drugs
5. Participation in another clinical study currently or during the past month

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the area under curve (AUC) of human-cl rhFVIII and Kogenate®/Helexate® for FVIII:C using both the chromogenic (CHR) and the one-stage (OS) assays and the actual potency of human-cl rhFVIII and Kogenate®/Helexate®.

Secondary Outcome Measures